510(k) K250073 ยท PDJ Hemoglobin A1c Test System
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
| Applicant | Tosoh Bioscience, Inc., Grove City OH, US |
| Decision | Substantially Equivalent, Oct 3, 2025 |
| Received | Jan 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250073
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.